Health TrialsbyHealthPanel

A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls

ConditionRenal Impairment
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShionogi

About this trial

The purpose of this study is to measure the pharmacokinetics, safety, and tolerability of S-892216 (S-892216-PO) in participants with mild, moderate, or severe renal impairment not on dialysis, or renal impairment requiring hemodialysis (HD), and in participants with normal renal function.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Considered to be healthy (for normal renal function participants) or medically stable (for participants with renal impairment), as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram during the screening period and on Day -1.

Participants With Severe, Moderate, and Mild Renal Impairment not on HD (Group A, D and E): Participants that are not undergoing HD and have mild, moderate, or severe renal impairment based upon the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula (estimated glomerular filtration rate [eGFR]) and the participant's body surface area (BSA) calculated at the screening visit.

Participants With Renal Impairment Requiring HD (Group B): Receiving stable HD at least 3 times a week for at least 6 months prior to screening

Participants With Normal Renal Function: Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by the 2021 CKD-EPI creatinine formula and the participant's BSA, must be normal (that is, eGFR ≥90 milliliters/minute).

Disqualifiers

Participants with life expectancy less than or equal to 3 months.

History or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data based on the judgment of the investigator.

Participants With Normal Renal Function: History or presence of renal disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.

Participants With Any Renal Impairment (Groups A, B, D, and E): Participant with clinically significant laboratory values in the opinion of the investigator or outside protocol-specified ranges or limits during the screening period or on Day -1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • S-892216-PO

    Drug

    S-892216-PO tablet will be administered orally.

Treatment groups

40 Participants
are divided into 5 treatment groups
Group A: Group A (Severe Renal Impairment)Experimental treatment 1 intervention
Group B: Group B (Renal Impairment)Experimental treatment 1 intervention
Group C: Group C (Normal Renal Function)Experimental treatment 1 intervention
Group D: Group D (Moderate Renal Impairment)Experimental treatment 1 intervention
Group E: Group D (Mild Renal Impairment)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maximum Plasma Concentration (Cmax) of S-892216

Time frame
Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
2

Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216

Time frame
Day 1 (predose up to 504 hours postdose) and Day 29 (predose up to 72 hours postdose) for Group B participants only
3

Group B Only: Cumulative Amount of the Drug Recovered in Dialysate (AHD) of S-892216

Time frame
Day 1 (up to 6 hours postdose)
4

Group B Only: Area Under the Dialysate Concentration in the Arterial Sides of Port-time Curve During Hemodialysis (AUChd) of S-892216

Time frame
Day 1 (up to 6 hours postdose)

Secondary outcomes

1

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame
Day 1 through Day 39

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shionogi

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator

Source ClinicalTrials.gov
Apply now